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Latest Job Openings

Position: Apigee Platform Engineer

Location: Irving, TX or Remote (East or Central Time Zone)

Duration: 12 months

Interview Process: 1 Technical Interview, 1 General Interview

Experience: 5+ years (or below with relevant expertise)

Start Date: May 2024

Responsibilities:

  1. Subject Matter Expertise (SME) in APIGEE (OPDK and/or Hybrid): Demonstrate proficiency in APIGEE platform operations, implementation, troubleshooting, monitoring, and management.

  2. Incident Analysis and Coordination: Analyze incidents, collaborate with application owners to troubleshoot and resolve issues related to the APIGEE platform.

  3. Platform Maintenance: Conduct platform upgrades, base image upgrades, certificate updates, scaling, and other maintenance tasks regularly.

  4. Root Cause Analysis: Lead root cause analysis sessions to identify production issues and devise preventive solutions for the future.

  5. Capacity Planning and Management: Participate in capacity planning activities to ensure the Apigee platform can accommodate current and future transactions.

  6. Adherence to SLAs: Ensure adherence to Service Level Agreements (SLAs) by resolving tickets promptly.

  7. System Health Monitoring: Conduct system health checks and report anomalies for proactive maintenance.

  8. Apigee Instance Management: Set up and manage Apigee instances/clusters distributed across data centers.

  9. On-call Support: Provide on-call support for the Apigee platform to address any emergent issues.

Requirements:

  • Solid experience in Apigee platform – APIGEE (OPDK and/or Hybrid).
  • Proficiency in managing the platform and providing production support.
  • Knowledge of Continuous Integration/Continuous Deployment (CI/CD) practices.
  • Experience in coordinating with application owners for issue resolution.
  • Ability to lead root cause analysis sessions and propose preventive measures.
  • Familiarity with capacity planning and management techniques.
  • Strong communication skills and ability to work effectively in a remote or distributed team environment.

Job Title: DB2 Systems Programmer – Remote

Location: Remote, USA

Shift: 2:00 PM CST to 10:00 PM CST

Job Type: Contract-for-hire basis

Overview: We are seeking a highly motivated DB2 Systems Programmer with extensive experience in installing and administering DB2 system software. This position requires working during odd hours and demands the ability to independently troubleshoot and resolve complex issues. The ideal candidate will have a strong background in mainframe systems, particularly with multiple LPARs and a Db2 Sysplex environment.

Responsibilities:

  • Install, configure, and maintain Db2 system software in a large-scale mainframe environment.
  • Monitor and manage Db2 instances across multiple LPARs and a Db2 Sysplex configuration.
  • Collaborate with cross-functional teams to implement production changes and handle on-call rotation duties.
  • Utilize TSO, ISPF, and JCL for system administration tasks and job stream creation/modification.
  • Allocate and manage z/OS datasets and file systems, including PDS/PDSE and VSAM.
  • Work with SMPE for software maintenance and updates, and administer zFS allocations.
  • Engage with vendors to manage support tickets and escalate issues as needed.
  • Analyze system performance using enterprise z System monitoring tools like Omegamon, Mainview, TMON, MXG, and Splunk.
  • Participate in Incident Management processes, including root cause analysis and resolution.
  • Mentor team members and provide technical guidance as necessary.

Requirements:

  • Proficiency in TSO, ISPF, JCL, and z/OS operations.
  • Experience with various z/OS file types and file systems, including PDS/PDSE and VSAM.
  • Familiarity with ITSM processes, including Incident and Change Management.
  • Ability to work independently and as part of a team in a high-pressure environment.
  • Strong problem-solving skills and the ability to analyze complex issues.
  • Minimum of 10 years of experience in mainframe systems, with a focus on Db2 software administration in a large-scale environment.
  • Experience with multiple LPARs, Db2 Sysplex configuration, and 24×7 on-call rotation.
  • Proven ability to communicate effectively and collaborate with stakeholders at all levels.

Nice to Have:

  • SME-level knowledge of SMP/E for software installation, administration, and support.

This role offers an exciting opportunity for a skilled DB2 Systems Programmer to contribute to the success of our mainframe environment, working remotely with a dedicated and dynamic team. If you meet the requirements and are eager to take on new challenges, we encourage you to apply.

PACKAGING DEVELOPMENT ENGINEERS:

Design, develop, and implement components used for the packaging of incoming raw materials, final product, and product shipment. Perform Gap analysis on existing document to align with the latest standards. Review validation documents including process validation plan documents, risk assessment, traceability matrix, and summary reports. Identify root causes for quality issues and compliance concerns and implement corrective actions. Master’s degree in Science, Technology, or Engineering (any) is required. Work location: Schaumburg, IL and various unanticipated locations throughout the U.S.

QUALITY ENGINEERS:

Lead and participate in investigations, develops plans and executes tasks to solve process problems including Non conformances (NC), complaint investigations and audit observations. Design and develop Risk Management plan and DFMEA and PFMEA. Develop and execute commissioning, IQ and PV protocols, changes requests, gap & root cause analysis, summary reports for facilities, equipment & processes. Write engineering change orders related to Corrective and Preventive Actions (CAPAs). Prepare, & submit documentation for quality compliance to regulatory authorities. Master’s degree in Science, Technology, or Engineering (any) with 1 year of experience in job offered or related occupation is required. Work location: Schaumburg, IL and various unanticipated locations throughout the U.S.

Send Resume to HR Dept., Worklance, Inc., 1821 Walden Office Square, Suite 400, Schaumburg, IL 60173.

 

Should the candidate accept employment with Worklance, Inc., the referring employee will be eligible to receive an award of $1,000.00 for the successful referral.

Fill out the form below 

Location: Bothell, WA

About Us:
The MSAT (Manufacturing Sciences and Technology) team at Juno Manufacturing Plant (Jump) is dedicated to maintaining the highest standards of quality and compliance in biotechnology and cellular therapy manufacturing. We are committed to driving innovation, continuous improvement, and ensuring regulatory adherence in all aspects of our operations.

Role Overview:
The Deviation Investigator is a pivotal role within the MSAT team, responsible for investigating and managing deviations to ensure compliance with regulatory standards. The successful candidate will collaborate cross-functionally, collect pertinent data, conduct thorough investigations, and implement corrective actions to prevent deviations from reoccurring. This role requires expertise in GMP compliance, strong communication skills, proactive problem-solving abilities, and a commitment to quality and continuous improvement.

Key Responsibilities:
Actively manage deviations to achieve Right First Time (RFT) and on-time phase completion, including deviation closure by the original due date.
Partner with investigation teams to define investigation plans, gather necessary data, and ensure alignment on root cause and Corrective and Preventive Actions (CAPA).
Facilitate the investigation/CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements.
Ensure smooth transition of CAPA to the owning department SME and timely implementation to ensure on-time deviation closure.
Lead investigation of department-specific trend deviations, including deep-dive analysis, root cause evaluation, and assessment of previous CAPA effectiveness.

Qualifications:
Minimum Bachelor’s degree in relevant Science or Engineering discipline or equivalent combination of work experience.
5+ years of relevant cGMP experience, preferably in the biotechnology and/or cellular therapy field.
Minimum of 2 years working within quality systems managing deviation and CAPA records.
Experience authoring deviation and CAPA records.
Demonstrated proficiency in GMP compliance and FDA/EMA regulations.
Excellent written and verbal communication skills.
Proven ability to work cross-functionally and develop strong business partner relationships.
Innovative, proactive, and resourceful mindset with a commitment to quality and continuous improvement.
Ability to anticipate and mitigate challenges effectively.

If interested, comment below or send your resume to:
puspanjali.s@worklanceinc.com
harsha@worklanceinc.com

Fill the form below.

Our client is a globally distinguished medical device manufacturer who specializes in the development and commercialization of innovative medical devices to improve patient lives around the world. Our client currently needs a Systems Engineer, specificaly referred to as a BLE Telemetry System Designer to support the development and design of Bluetooth Low Energy (BLE) telemetry systems used in medical devices.

 location:

Minneapolis, MN

Responsibilities: 

  • Design and develop Bluetooth Low Energy (BLE) telemetry systems for medical devices, ensuring compliance with industry standards, regulations, and best practices
  • Collaborate with hardware and firmware engineers to define system requirements and develop specifications for BLE-based communication protocols
  • Conduct feasibility studies and evaluate different hardware and software solutions to identify the most suitable options for BLE integration
  • Create detailed system architecture and design documentation, including block diagrams, flowcharts, and interface specifications
  • Develop and implement software algorithms and protocols for data transmission, synchronization, and error handling within the BLE telemetry system
  • Perform system-level testing and verification, including integration testing and troubleshooting of hardware and software components
  • Collaborate with external vendors and suppliers to source and evaluate BLE modules, sensors, and other components required for the telemetry system
  • Collaborate with cross-functional teams to ensure seamless integration of the BLE telemetry system into the overall medical device design

Qualifications

  • BS Degree Minimum, and 4-7 years of Medical Device experience
  • Proven experience in designing and developing BLE telemetry systems for medical devices or a related industry
  • Proficiency in software development using programming languages such as C, C++, or Python
  • Familiarity with wireless communication technologies and protocols (e.g., Wi-Fi, Zigbee, NFC).
  • Experience in hardware and firmware integration, including circuit design, PCB layout, and debugging
  • Solid understanding of medical device regulations and standards, such as ISO 13485 and FDA guidelines

Preferred Skills: 

  • Experience with wireless medical device connectivity and interoperability standards, such as IEEE 11073
  • Familiarity with data encryption and security protocols for BLE communication in medical devices
  • Knowledge of embedded systems and real-time operating systems (RTOS).
  • Experience with software development tools and methodologies, such as Agile or Scrum
  • Familiarity with medical device risk management processes, including hazard analysis and mitigations

Position: Senior Quality Engineer

Company: Our prestigious client in the Medical Device industry is currently seeking a qualified individual for the role of Senior Quality Engineer on a contracting basis. This challenging position requires active involvement in a dynamic team of QA Engineers dedicated to managing numerous projects continuously, with a primary focus on the development of new products, Change Management (LCMs), and initiating the new pipeline (MPD) within the R&D Wound Closure domain.

Required Experience:

  • Minimum of 4 years of work experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical).
  • Significant experience in the medical device industry, preferably with a diverse product background.
  • Analytical Proficiency: Strong statistical analysis skills with a thorough understanding of compliance and regulatory requirements. The ideal candidate should excel in crafting comprehensive documentation.
  • Quality System Knowledge: Fundamental understanding of Quality Systems Regulations (QSR), including Design Control, and Good Manufacturing Practices (GMP).
    • Medical Device product risk management
    • Medical devices process validation
  • Ability to develop and present to leadership.
  • Strong collaboration and teaming skills in a diverse team environment are essential.
  • Onsite Commitment: The role requires individuals to be onsite for a minimum of 3-4 days a week, in alignment with the ongoing needs of the business.
  • Bachelor’s Degree in Engineering, Biology, Science, Chemistry, or related technical field is required.

Preferred Qualifications:

  • Advanced Degree
  • Prior experience in a Quality/Quality Engineering role.
  • Fundamental understanding of pharmaceutical GMPs.
  • Experience in statistical analysis and statistical analysis tools such as Minitab is preferred.
  • Experience in applying various risk management and risk mitigation tools.
  • Experience with Test Method Validations, Root Cause Analysis, CAPA & Non-Conformance Management, and Process Validations.

Application Process:

If you meet the aforementioned qualifications and are eager to contribute to our team or fill out the form below,  We anticipate reviewing your application.

Key Responsibilities:

  • Conduct equipment instrument qualification and Installation Qualification (IOQs).
  • Safeguard data integrity throughout the validation process.
  • Develop and meticulously document validation materials, including system configurations, specifications, user requirements, and risk assessments.
  • Leverage your experience in the pharmaceutical industry to ensure compliance with industry-specific practices and regulations.
  • Empower Software experience is a definite plus, enhancing the efficiency of the validation process.

Requirements:

  • Minimum of a Bachelor’s degree in a relevant field.
  • A minimum of 4 years of experience in a similar role.
  • Prior experience within the pharmaceutical industry is essential.
  • Familiarity with Empower Software is advantageous.

Details:

  • Location: Bothell, WA (North Creek facility).

Location: Albany, NY

Duration: 6+ Months

Job Type: Contract

Responsibilities:

  1. Cleaning Validation Protocol Development:

    • Develop, review, and execute cleaning validation protocols for equipment, with a focus on manual cleaning processes such as swabbing and rinsing.
  2. Risk Assessment and Mitigation:

    • Assess potential risks related to cleaning processes and implement necessary corrective and preventive actions.
  3. Execution and Documentation:

    • Perform hands-on validation activities, including swabbing and rinsing procedures, and maintain thorough documentation of all activities.
  4. Analytical Testing Oversight:

    • Coordinate and oversee analytical testing of cleaning samples, working closely with the Quality Control team to interpret results.
  5. Collaboration and Communication:

    • Collaborate with manufacturing, quality assurance, and regulatory affairs teams to ensure alignment with industry standards and regulatory requirements.
  6. Continuous Improvement:

    • Identify opportunities for process improvement and efficiency in cleaning validation procedures, implementing best practices and staying informed about industry trends.

Apply Now – Fill out the form Below 

Job Opportunity: Senior Packaging Engineer

Location: New Jersey (NJ)
Rate: $50-55 per hour
Duration: 12-month contract

Company Overview: Join a global leader in the consumer goods industry, dedicated to delivering innovative products. Seeking a talented Senior Packaging Engineer to lead packaging development.

Key Responsibilities:

  • Primary and Secondary Package Development:

    • Lead design and development for new/existing products.
    • Ensure packaging meets requirements, standards, and sustainability goals.
  • Research and Development (R&D):

    • Drive innovation in packaging materials, processes, and technologies.
    • Conduct feasibility studies and stay updated on industry trends.
  • Project Lead Capacity:

    • Manage projects from concept to commercialization.
    • Develop timelines, milestones, and budgets for timely delivery.
  • Cross-Functional Team Leadership:

    • Collaborate with R&D, manufacturing, marketing, and QA teams.
    • Foster a collaborative environment encouraging creativity and problem-solving.
  • Commercialization Qualification:

    • Demonstrate a track record of successful packaging commercialization.
    • Conduct testing and validation for packaging performance and compliance.

Qualifications:

  • Bachelor’s degree in Packaging Engineering, Biomedical, Mechanical, or related field.
  • 5+ years of professional experience in the high-volume consumer electronics industry.

If passionate about packaging innovation and ready to contribute to a dynamic team, apply to the below form. Fill the form below

 

Apply to Your Dream Job Soon!

Believe in yourself, acknowledge your strengths, and go after what sets your soul on fire. Your journey to success begins with this application.

Best of luck, and remember – your dreams are within reach!
 
Testimonials

My Happy Clients!

I extend my heartfelt appreciation to the Worklance team for their exceptional service in the Medical Device and Pharmaceutical industry. From project initiation, their professionalism and expertise set a remarkable standard. Their profound knowledge enriched our endeavors, providing invaluable insights. Worklance consistently exceeded expectations, showcasing dedication and proficiency. I wholeheartedly recommend their services for unparalleled expertise and outstanding results. Gratitude to Worklance for their outstanding support.
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Anoop kumar
Project Manager (Jonson & Johnson)

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